Founder and chief executive officer of ImmunoTox, Inc., Kimber White, Ph.D. said, “We are looking forward to the opportunities that come with aligning ourselves with AIBioTech. Our capabilities complement AIBioTech’s existing assay design and immunology services very well.”
Dr. White will continue to serve as a consultant for AIBioTech. Other key employees of ImmunoTox have accepted positions and together with the acquisition of all necessary instrumentation, the ImmunoTox division will be able to continue its service offerings.
“We intend to leverage the expertise of ImmunoTox into expanded service offerings for our current customers including for the first time, flow cytometry,” said AIBioTech president and chief scientific officer Robert B. Harris, Ph.D. “The ability to monitor the immune response of the host organism is a critical component along the path of drug (and chemical) development, and by adding these services to our research support repertoire, AIBioTech becomes even more competitive as the preferred full service contract research organization.”
Kemwell Expands Lyophilization Capacity
Kemwell Biopharma has expanded its lyophilization capacity with the installation and qualification of a commercial scale
lyophilizer, adding GMP lyophilization capability to its sterile injectable offerings for biologics and pharmaceuticals.
The lyophilizer has a shelf area of 80 sq.- ft. and is equipped with CIP and SIP facility. The maximum batch size ranges from 4,000 (50ml vial) to 29,000 (2ml vial). With the expansion, the company offers the complete range from lyo-cycle development, small-scale manufacturing for preclinical studies and GMP manufacturing of lyophilized vials for clinical and commercial products.
According to Anurag Bagaria, chairman and managing director, “The outsourcing of services in bio/pharmaceutical industry is growing and Kemwell will continue to invest into technologies to support our customers’ needs.” In 2008, Kemwell entered into a strategic collaboration with Boehringer Ingelheim, Germany. These facilities have been designed with the engineering and operational support of Boehringer Ingelheim.
Gallus Inks Mfg. Agreement with Symphogen
Gallus BioPharmaceuticals has signed a manufacturing agreement with Symphogen, A/S for the process transfer and clinical stage cGMP manufacture of Symphogen’s antibody mixture product candidates. Gallus will employ the GE Healthcare Life Sciences Flex Factory, a single-use biomanufacturing platform, at its headquarters in St. Louis to manufacture product candidates.
“Gallus is delighted to partner with Symphogen in the process development and clinical supply of their antibody mixture candidates. Symphogen has developed unique technologies for the controlled, reproducible production of highly characterized mAb mixtures manufactured in a single batch. Gallus’ expertise in process development and scale-up will ensure high quality molecules are delivered to the clinic,” said Mark R. Bamforth, Gallus’ president and chief executive officer.
“We are pleased to work with Gallus, a very experienced CMO with an extensive background in the cGMP manufacture of antibodies, ranging from early stage clinical programs to the commercial supply of approved therapeutics. We look forward to working together to advance our innovative cancer therapeutic programs,” said Kirsten Drejer, chief executive officer of Symphogen.
Aesica’s Queenborough Site Completes Validation
Aesica’s high capacity manufacturing facility at its Queenborough, UK site has been successfully validated for commercial production. The company invested $45 million to expand commercial production for a solid dose medication used to treat Type 2 diabetes. The product is sold globally and is ready for worldwide export.
The expanded facility is capable of producing more than 1 billion tablets per year and was designed to accommodate potential future expansion to produce more than 2.5 billion tablets a year. The new facility contains highly technical and specialist equipment including spray granulators, coaters, tablet presses, powder handling systems and large capacity blenders. The company added 10,000 square meters to the existing Queenborough site and has a dedicated workforce of 55 technicians, with future expansion plans to increase the staffing level to more than 100.
Dr. Robert Hardy, chief executive officer of Aesica Pharmaceuticals, said, “The validation of this facility for commercial production is a major milestone for the company and brings to fruition what has been a significant investment. Aesica is already a major exporter of finished dose products and the investment in this facility reflects the continued growth in export demand. This state-of-the-art facility will allow us to manufacture a high quality product used to treat one of the world’s most prevalent diseases and has the capability to double its capacity in the future, representing an expanding revenue stream for Aesica.”
Bayer To Establish Manufacturing Capacity in Germany
Bayer HealthCare is investing more than €500 million to establish manufacturing capacity for recombinant factor VIII (rFVIII) hemophilia products that are currently in development at its sites in Wuppertal and Leverkusen, Germany. The company’s two investigational therapies for hemophilia A are currently in Phase III development. Bayer’s approved hemophilia A product is manufactured exclusively in Berkeley, CA. The additional supply source in Germany will help prepare for production of the new therapies upon approval.
“This investment will be one of the largest in the history of Bayer HealthCare and reflects our strong commitment in the hemophilia field,” said Dr. Olivier Brandicourt, chief executive officer of Bayer HealthCare.
Almac Expands Asia Pacific Ops
Almac has expanded its clinical services and technologies capabilities with regional hubs in Singapore and Japan to provide leadership, as well as technical, project and operational resources in Asia. The company is also establishing a new secondary packaging facility in Singapore to supply management and support drug pooling strategies aimed at optimizing the supply chain, which will open by the end of the year.
Almac’s local teams support studies of various sizes and complexity and services are augmented by a web-based interface to monitor trial execution globally, with multi-lingual technical and project teams, and an in-house 24/7 hotline connecting site staff to on-call clinicians and unblinding specialists. According to the company, by positioning operational resources within the same time zones where trials are executed, Almac is able to resolve issues in less than 24 hours to eliminate communication delays and improve patient care.
Alan Armstrong, chief executive officer of Almac, said, “With 15% of all clinical trials conducted in Asia, it’s imperative that we provide localized service and support to our clients. We’ve long managed clinical trials on a global basis, but there’s now sufficient critical mass that requires we establish dedicated resources in the region. I’m pleased that our international expertise and global capabilities are now even more accessible to sponsors in this critically-important part of the world, and look forward to opening our new packaging facility later this year.”
Catalent Launches ADVASEPT Technology
Catalent Pharma Solutions has launched its new ADVASEPT technology for the aseptic filling of injectable drugs. According to the company, the new platform provides a glass-free, aseptically filled, primary container that reduces or eliminates many concerns associated with traditional glass vials, including the risk of injuries to treatment providers and patients, the potential for glass particulate contamination and accidental breakage in transit, and subsequent product wastage.
ADVASEPT vial production leverages Quality by Design manufacturing techniques designed to optimize the blow-fill-seal manufacturing process. According to the company, a stopper is inserted during the blow-fill-seal process to create a next generation, glass-free injectable solution, minimizing the risk of contamination by reducing particles, process steps, and human interaction. The ADVASEPT stoppered vial is currently available in 10mL, 50mL and 100 mL sizes, with pop-off or twist-off tops. The vials are manufactured at Catalent’s Woodstock, IL facility, and are customizable. Containers can be tailored to meet specific customer needs across biologics, pharmaceuticals, generics, and animal health.
“This new technology eliminates the risk of glass particulate contamination, significantly reduces the risk of breakages and minimizes container weight through the use of an ultrapure plastic design,” said Catalent’s Jonathan Arnold, vice president and general manager of Advanced Delivery Technologies. “Catalent also brings analytical expertise in areas such as biologic substance testing, extractables and leachables, and stability, and we have scientifically shown comparability of a monoclonal antibody between traditional glass and ADVASEPT vials.”
PCI Expands Packaging Capacity
Packaging Coordinators, Inc. (PCI) has completed the expansion of its contract packaging facilities in Rockford, IL, adding 20,000 sq.-ft. for secondary and tertiary packaging operations. The additional production capacity allows for continued growth of its cartoning, overwrapping, heat seal carding and compliance prompting packaging, as well as supports packaging for biotech delivery forms such as secondary packaging for injectable vials, syringes, devices, and transdermal products. The packaging operations support both commercial operations as well as large-scale clinical studies.
“The facilities expansion we have undertaken in Rockford is the latest in a series of investments we have made to enable continued growth and at the same time continue to provide our customers the extraordinary service they have come to expect from PCI,” said Bill Mitchell, president and chief executive officer at PCI. “We are committed to providing an unparalleled customer experience with our clinical and commercial services, and those services require world class facilities. We are very excited about what these investments bring to our expanding business and our ability to support our clients.”
Quincy Bioscience Receives NSF GMP Recertification
Quincy Bioscience has received recertification of its GMP facilities registered by NSF International for 2014. The GMP registration verifies that the company has the proper methods, equipment, facilities, and controls in place for producing dietary supplement products in accordance with the FDA’s 21 CFR part 111 regulations on manufacturing, packaging, and distribution.
“We’re proud to maintain this important recognition for all of our locations,” said Mark Underwood, president and co-founder of Quincy Bioscience. “We take good manufacturing practices very seriously in every department of our organization and we’re pleased that NSF continues to acknowledge our practice of excellence.”